Biowaivers: Practical and Regulatory Approaches

A biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for approval). As a result, they represent a useful and cost-effective alternative to performing in vivo studies for generic drugs, however they can be challenging to get right first time.  
 
This course will improve your understanding of various biowaiver types to ensure success in your future applications. Study 8 modules over 4 weeks, using case studies and practical guidance. By examining the requirements for BCS-based, Strength and IVIVC biowaivers, you will have the confidence and skills to implement a strategic approach for new product registrations. 

If you would like to start the course sooner than advertised simply get in contact with our training consultants by emailing [email protected] and we will arrange this for you as soon as possible.